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	<pub:InProceedings rdf:about="http://ebiquity.umbc.edu/paper/html/id/1180/Semantically-Rich-Approach-to-Automating-Regulations-of-Medical-Devices">
		<rdfs:label><![CDATA[Semantically Rich Approach to Automating Regulations of Medical Devices]]></rdfs:label>
		<pub:title><![CDATA[Semantically Rich Approach to Automating Regulations of Medical Devices]]></pub:title>
		<pub:publishedOn rdf:datatype="&xsd;dateTime">2024-07-11T00:00:00-05:00</pub:publishedOn>
		<pub:abstract><![CDATA[Advanced medical devices increasingly use sophisticated AI/ML models to enable real-time analytics for monitoring patients. In the US, these AI models, which often form the underlying device software, are regulated by the Center for Devices & Radiological Health (CDRH) at the Food & Drug Administration (FDA) to ensure the safety & efficacy of the medical device. These regulations for medical devices are currently available as large textual documents, called Code of Federal Regulations (CFR) Title 21, that cross-reference other documents & so require substantial human effort to parse & comprehend. Hence, the device manufacturers incur significant costs during the regulatory process to adhere to all the rules & policies laid down by the FDA. We have developed a novel, semantically rich approach to extract the knowledge from the rules & policies for Medical devices & translate it into a machine-processable format that can be reasoned over. This framework was developed using AI/Knowledge Management approaches & Semantic Web technologies like OWL/RDF & SPARQL. This paper presents the detailed Ontology/Knowledge graph we developed for medical device regulations & the Use case results that validate our design. Regulators & manufacturers alike can use our framework to significantly reduce the human effort required during the device regulatory process.]]></pub:abstract>
		<pub:organization><![CDATA[IEEE]]></pub:organization>
		<pub:counter>1410</pub:counter>
		<pub:tag><![CDATA[semantic web; knowledge graph; medical device; compliance; code of federal regulations.]]></pub:tag>
		<pub:booktitle><![CDATA[IEEE International Conference on Digital Health (ICDH) , 2024 at IEEE World Congress on Services 2024]]></pub:booktitle>
		<pub:publisher><![CDATA[IEEE]]></pub:publisher>
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					<person:Person rdf:about="http://ebiquity.umbc.edu/person/html/Karuna/Joshi"><person:name><![CDATA[Karuna Pande Joshi]]></person:name><rdfs:label><![CDATA[Karuna Pande Joshi]]></rdfs:label></person:Person>
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							<person:Person rdf:about="http://ebiquity.umbc.edu/person/html/Subhankar/Chattoraj"><person:name><![CDATA[Subhankar Chattoraj]]></person:name><rdfs:label><![CDATA[Subhankar Chattoraj]]></rdfs:label></person:Person>
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<person:Person rdf:about="http://ebiquity.umbc.edu/person/html/Karuna/Joshi"><person:name><![CDATA[Karuna Pande Joshi]]></person:name><rdfs:label><![CDATA[Karuna Pande Joshi]]></rdfs:label></person:Person>
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			<pub:softCopyURI><![CDATA[http://ebiquity.umbc.edu/get/a/publication/1400.pdf]]></pub:softCopyURI>
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